Phase
Condition
Neoplasms
Treatment
Adagrasib
Cetuximab
Nivolumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be ≥ 18 years of age.
Histologically confirmed diagnosis of a locally advanced and unresectable ormetastatic solid tumor malignancy with any of the following tumor types:.
Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC),non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductaladenocarcinoma (PDAC).
Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation.
ii) Part 2B: NSCLC with KRAS G12C mutation.
iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.
Participants must have an Eastern Cooperative Oncology Groups (ECOG) PerformanceStatus of 0 or 1.
Participants must have measurable disease per RECIST v1.1.
Exclusion
Exclusion Criteria:
Untreated central nervous system (CNS) metastases.
Leptomeningeal metastasis (carcinomatous meningitis).
Impaired cardiac function or clinically significant cardiac disease.
For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD).
ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Other protocol-defined inclusion/exclusion criteria apply.
Study Design
Connect with a study center
Local Institution - 0031
Brisbane, Queensland 4029
AustraliaSite Not Available
Royal Brisbane and Women's Hospital
Brisbane 2174003, Queensland 2152274 4029
AustraliaActive - Recruiting
BC Cancer Vancouver
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
Local Institution - 0032
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
BC Cancer Vancouver
Vancouver 6173331, British Columbia 5909050 V5Z 4E6
CanadaActive - Recruiting
Local Institution - 0015
Montréal, Quebec H2X 0A9
CanadaSite Not Available
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Quebec City, Quebec G1J 1Z4
CanadaSite Not Available
Local Institution - 0016
Quebec City, Quebec G1J 1Z4
CanadaSite Not Available
Local Institution - 0015
Montreal 6077243, Quebec 6115047 H2X 0A9
CanadaSite Not Available
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec 6325494, Quebec 6115047 G1J 1Z4
CanadaActive - Recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Local Institution - 0021
Hackensack, New Jersey 07601
United StatesSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United StatesSite Not Available
Local Institution - 0020
Allentown, Pennsylvania 18103
United StatesSite Not Available
Lehigh Valley Health Network
Allentown 5178127, Pennsylvania 6254927 18103
United StatesActive - Recruiting
Local Institution - 0024
Germantown, Tennessee 38138
United StatesSite Not Available
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38138
United StatesSite Not Available
The West Clinic, PLLC dba West Cancer Center
Germantown 4624601, Tennessee 4662168 38138
United StatesActive - Recruiting
Local Institution - 0025
Dallas, Texas 75390
United StatesSite Not Available
Local Institution - 0025
Dallas 4684888, Texas 4736286 75390
United StatesSite Not Available

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